Kornimate/medical-research-clean huggingface dataset:
exploratory study of the microbiome of upper gastrointestinal in the pathogenesis of multiple primary lung cancer

Conditions: Multiple Primary Lung Cancer; Microbial Colonization

Summary: this is an exploratory, single-center, being conducted at beijing haidian hospital in order to detect the relationship between microbiome of upper gastrointestinal and pathogenesis of multiple primary lung cancer.

this study intends to analyze the bacterial community structure of respiratory tract, upper digestive tract, lesion and adjacent to cancer in patients with multiple primary lung cancer, and to explore the association between upper digestive tract bacterial community and lung microecology, in order to find the characteristics of upper digestive tract bacterial strains involved in regulating lung cancer microenvironment, and explore the possible interaction mechanism between upper digestive tract bacterial community and lung cancer gene mutation.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age (including 18 years of age, male or female) and voluntarily signed informed consent; 2. chest ct imaging showed at least 2 pulmonary nodules with a diameter of less than 3cm in ipsilateral lung, and imaging diagnosis of highly suspicious multiple primary lung cancer 3. no surgical contraindication, surgical resection is feasible, and postoperative pathology is diagnosed as multiple primary lung cancer according to martini and melamed criteria and gene testing 4. the amount of at least 2 or more tissues removed from multiple pulmonary nodules must meet the requirements of pathological diagnosis, molecular detection and microflora detection exclusion criteria: 1. under 18 years of age (excluding 18 years of age, male or female) or unwilling to sign informed consent; 2. severe heart, liver, brain, kidney and other important organ diseases and bone marrow hematopoietic dysfunction; 3. preoperative examination of patients who cannot tolerate surgical resection 4. patients who received antibiotics within 1 week before surgery e) resected multiple pulmonary nodules with pathologically proven lung cancer of less than 2 patients 5. multiple nodules resected were confirmed to be metastases, not primary lung cancer

Keywords: multiple primary lung cancer microbiome
assessment of dha on reducing early preterm birth

Conditions: Preterm Birth

Summary: the purpose of this study is to determine if giving a larger amount of dha than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).

docosahexaenoic acid (dha) is a nutrient found in some fish and eggs and its intake in us diets is typically low. because dha is important for early brain development, it has recently been added to many prenatal supplements. the usual amount is around 200 mg/day. participants in this study are guaranteed to receive at least 200 mg/day of dha. almost 5 in 100 births in the us occur before 34 weeks of pregnancy. there is no way to predict which births will occur before 34 weeks. in an earlier study conducted at the university of kansas medical center, women who received 600 mg dha/day compared to no dha had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth. this study is designed to compare standard care (200 mg/day of dha) to a higher amount of dha (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). individual participation in this study is expected last about 5 months.

Eligibility criteria:
inclusion criteria: * pregnant females 18 years and older 12 to 20 weeks gestation at study entry * agree to consume study capsules and a typical prenatal supplement of 200 mg dha * available by telephone * able to speak and read in either english or spanish language exclusion criteria: * expecting multiple infants * gestational age at baseline \ 20 weeks * unable or unwilling to agree to consume capsules until delivery * unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg dha per day * women with allergy to any component of dha product (including algae), soybean oil or corn oil

Keywords: preterm birth early preterm birth very low birth weight low birth weight pregnancy outcome docosahexaenoic acid (dha) randomized cliinical trial superiority trial adaptive design
the red blood cells based blood test for lung cancer early detection

Conditions: Lung Cancer; Red Blood Cells; Methylation

Summary: this study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose dna and rna will be extracted from mature red blood cells isolated from peripheral blood. the dna 5-methylcytosine(5-mc) and rna 2'-o-methylation information will be acquired by ngs and nm judge universally sequencing (nju-seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. the pathological results will be acquired after surgery or biopsy as standard in the study.

this is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in china. each participant pulmonary nodule is ≤30mm as assessed by ct scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.their blood samples, ct scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy. each subject will analysis dna and rna methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (ngs) . a proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. sensitivity and specificity of the different methylation panels will be to evaluated.

Eligibility criteria:
inclusion criteria: 1. pulmonary nodule is ≤3cm; 2. subjects suspected of lung cancer; 3. diagnosis or treatment by biopsy or surgery within 60 days; 4. signed informed consent. exclusion criteria: 1. history of malignant tumors; 2. received anti-tumor therapy; 3. can't collect the histopathological results or the pathological results are metastatic cancer; 4. can't obtain detection information of red blood cells; 5. pregnancy or lactating female； 6. other situations not suitable for the study.
trial to evaluate the safety and efficacy of maraviroc in patients hospitalized for coronavirus disease 2019 (covid-19)

Conditions: Virus Diseases

Summary: maraviroc (mvc) is a drug, very well tolerated, it has been seen that mvc has properties of modulating the immune system, exerting an anti-inflammatory effect in different diseases. in covid-19, very high levels of inflammation occur that cause organs and systems to be damaged. mvc could reduce this inflammation achieving a better prognosis of covid-19.

in this clinical trial the investigators want to evaluate if standard treatment together with maraviroc (mvc) compared to standard treatment alone, achieves better clinical evolution in participants hospitalized for covid-19.

Eligibility criteria:
inclusion criteria: * subjects aged ≥ 18 years. * infection confirmed by sars-cov-2 by polymerase chain reaction (pcr) at least 3 days before randomization. * hospitalized or emergency patient in hospitalization phase. * mild / moderate pneumonia, with fever, persistent cough and severe asthenia, confirmed by imaging tests (conventional radiology or computerized axial tomography (ct)) with ambient air oxygen saturation (sato2)\> 94%. * less than 12 days from the onset of symptoms. * women of childbearing potential must have a negative serum or urine pregnancy test prior to inclusion in the study and must commit to using highly effective contraceptive methods (intrauterine device, bilateral tubal occlusion, vasectomized partner, and sexual abstinence). * accepts written consent or oral informed in the case that due to the relevant security protocols, written consent is not possible. exclusion criteria: * patient with severe pneumonia confirmed by imaging test (conventional radiology or computerized axial tomography (ct)) with ambient air oxygen saturation (sato2) ≤94%. * another acute active infection other than that produced by sars-cov-2. * chronic renal failure (estimated glomerular filtration ≤ 30 ml / min / 1.73 m2 or receiving renal replacement therapy in any of its modalities). * known hiv infection. unless the patient has\> 500 cd4 + / mm3 and an undetectable viral load for more than 6 months. * active co-infection with known hepatitis b or c viruses. * cirrhosis, portal hypertension and / or hypersplenism of any etiology. * past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy * laboratory abnormalities. * concomitant use of drugs with major pharmacological interactions with the study drugs, according to the respective technical specifications of the products. * pregnancy.

Keywords: sar-cov19 coronavirus covid19
a long term safety study of mavrilimumab in adult subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (ra), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. this study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. the data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with ra. in addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.

Eligibility criteria:
inclusion criteria: * subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization. * no evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist exclusion criteria: * subjects who have been permanently discontinued from investigational product in previous qualifying study. * any new conditions or worsening of any pre-existing conditions as defined in the protocol.
fimasartan (br-a-657) multiple oral dose in healthy subjects

Conditions: Essential Hypertension

Summary: the objective of this study is to determine the safety and tolerability and to determine the pharmacokinetic and pharmacodynamic(pk/pd) of ascending multiple oral dose of br-a-657 in healthy male subjects.

br-a-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects. pharmacokinetic and pharmacodynamic(pk/pd) parameters were monitored at pre-specified times from each subjects. pk parameters: area under the curve(auc), cmax, half-life, etc. pd parameters: aldosterone, plasma renin activity, angiotensin i, angiotensin ii adverse events are reported.

Eligibility criteria:
inclusion criteria: * male of 18-55 years old * bmi 19-29kg/m2 * subjects in good health * subjects with written informed consent exclusion criteria: * subjects with multiple drug allergy or allergy to arb * subjects with medication that affect drug absorption or elimination within 30days. * subjects with orthostatic hypotension of \>20mmhg decrease of sbp * subjects with history of neurologic, liver, renal, gi, cv, psychological or other major disorder

Keywords: br-a-657 fimasartan multiple-dose pharmacokinetic pharmacodynamic safety
anti-plaque and anti-gingivitis effects of moringa plant extract and fluoride toothpastes

Conditions: Oral Disease

Summary: the present study aims to assess and compare the anti-plaque and anti-gingivitis effects of moringa plant extract and fluoride toothpastes among a group of egyptian children.

in the last few years, the use of plant extracts in alternative medicine has evolved widely. various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .

Eligibility criteria:
inclusion criteria: * children of 12-14 years of age. * presence of gingivitis-calculus, and plaque (gingival index \[gi\]score ≥1/plaque index \[pi\] score ≥1). * children willing to participate. * children whose parents/caretakers gave informed consent. exclusion criteria * children having fixed or removable orthodontic appliances or removable prostheses. * children suffering from any systemic illness. * children who were already using mouthwashes. * history of oral prophylaxis within 6 months. * children using any other oral hygiene aids.
improving pain management via spinal cord stimulation and blood pressure reduction

Conditions: Chronic Pain; Hypertension; Diuretics Drug Reactions; SCS

Summary: the purpose of this study (passion study) is to monitor symptoms of chronic pain before and after 2 weeks of a standard drug commonly used to treat elevated blood pressure compared with 2 weeks of placebo (crossover design) so that we may better understand how blood pressure affects your level of pain. this study is not testing an experimental drug.

the goal of the passion study is to determine the extent to which reductions in blood pressure improve pain management via scs 1. examine the extent to which reductions in blood pressure (2 weeks of diuretic and 2 weeks of placebo) improve pain management among patients with chronic pain and hypertension compared. 2. examine the extent to which arterial baroreflex function, which is critical to blood pressure regulation, is impaired in patients with chronic pain and hypertension and is correlated with chronic pain symptoms.

Eligibility criteria:
inclusion criteria: 1. male or female, age 40-79 2. chronic low back pain 3. permanent spinal cord stimulator implant for chronic pain 4. stage 1 hypertension (bp 130-139/80-89 mmhg) with ascvd risk ≥10% 5. stage 2 hypertension (bp ≥ 140/90 mmhg) 6. willing to visit research lab (fairway ctsu) 7. willing to undergo a blood draw 8. able to provide written informed consent exclusion criteria: 1. any history of abnormal responses (allergy) to thiazide-type drugs 2. currently taking any antihypertensive medication 3. stage 1 hypertension (bp 130-139/80-89 mmhg) with ascvd risk \<10% 4. bp ≥160/100 (these patients should be promptly treated with 2 medications) 5. secondary hypertension (e.g., aldosteronism, renal artery stenosis) 6. symptomatic hypotension (weakness or syncope upon standing) 7. renal failure 8. diabetes requiring insulin or glucose-lowering drugs 9. history of neurological disease (e.g., dementias, parkinson's) 10. history of stroke 11. current diagnosis of cancer 12. women who are pregnant or planning to become pregnant 13. any active infection 14. subject is unwilling or unable to comply with the protocol 15. if currently taking a nsaid, willing to stop for at least 3 days prior to beginning study and throughout study
airway pressure during nasal high flow and cpap in neonates

Conditions: Respiratory Insufficiency

Summary: nasal high flow (nhf) and cpap are established forms of respiratory support in neonates and often produce similar clinical outcomes. the aim of the study was to investigate airway pressure during nhf and cpap in neonates.

methods: a physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (millar, usa) in 10 (5m / 5f) healthy newborns with mean gestation age 37.18 (sd 1.29) wk and mean birth weight of 2414 (sd 503.13) g. nhf was applied at 8 l/min (airvo 2) through smaller (opt 314) and larger (opt 316) optiflow nasal cannula; cpap 5 cmh20 was produced by a bubble cpap system and nasal mask interface at constant flow 8 l/min (fisher \& paykel healthcare, nz). values are expressed in cmh20 as means and standard deviations (sd).

Eligibility criteria:
inclusion criteria: * healthy term newborns exclusion criteria: * newborns with any medical problems after birth * absent of parents consents

Keywords: nasal high flow cpap airway pressure newborn
hscrp in japan statin treatment against recurrent stroke (j-stars hscrp)

Conditions: Ischemic Stroke

Summary: inhibition of 3-hydroxy-3-methylglutaryl-coenzyme a(hmg-coa) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. serum high sensitive crp is known to be a predictor of cardiovascular events independent of other conventional risk factors. the present substudy examine whether such pleiotrophic effect of hmg-coa reductase inhibitor (statin) which decreases high sensitive crp would be observed in the post-ischemic stroke patients who have already been registered in the j-stars, and the relationship the values of high sensitive crp and recurrence of stroke.


Eligibility criteria:
inclusion criteria: * ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset * hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days * able to visit outpatient department * informed consent on the form filled in by the patient. exclusion criteria: * ischemic stroke of other determined cause according to the toast classification * ischemic heart disease and necessary to use statin * hemorrhagic disorders * platelet count \<=100,000/ul within 3 months prior to study start * alanine aminotransferase (alt) or aspartate aminotransferase (ast)\>= 100iu/l within 3 months prior to study start * serum creatinine \>=2.0mg/dl within 3 months prior to study start * a scheduled operation * the presence of malignant disorder

Keywords: stroke brain ischemia cerebrovascular accident statin hydroxymethylglutaryl-coa reductase inhibitors cholesterol hypercholesterolemia hyperlipidemia multicenter studies prospective studies endpoint determination randomized controlled trials recurrence pravastatin c-reactive protein
registry measuring impact of rna expression testing on treatment decisions in early stage lung cancer and assessing the disease-free survival with long-term follow-up (onc006)

Conditions: Lung Cancer; NSCLC; NSCLC Adenocarcinoma

Summary: this registry is intended to measure the effect of myplan lung cancer™ test has on influencing treatment decisions of oncologists when added to standard clinical-pathological parameters in patients with early stage nsclc. the sponsor is conducting two parallel registries, with one directed at surgeons (onc003) and the other at oncologists (onc006). this registry is specific to oncologists (onc006).


Eligibility criteria:
inclusion criteria: * diagnosis of early stage non-small cell lung adenocarcinoma * sub-population staging (ia, ib or iia) as judged by the standard of practice at the investigational site * resection of tumor within previous 2 months of enrollment * ecog performance of 0-2 * a minimum life expectancy of six months exclusion criteria * previous myplan lung cancer test performed * pre-operative radiation or chemotherapy for nsclc * post-operative radiation or chemotherapy for nsclc * enrollment in a separate clinical trial restricting treatment options * unable to provide informed consent

Keywords: registry
characterization of auditory processing involved in the encoding of speech sounds

Conditions: Language Impairment; Hearing Loss

Summary: the ability to encode the speech signal is determined by ascending and descending auditory processing. difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. however, little is known about the underlying pathophysiological mechanisms. the assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). the two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.


Eligibility criteria:
inclusion criteria: for all subjects: * native french speaker * no medical treatment for behavior or neurological disorders * normal or corrected vision * right-handed * normal otorhinolaryngology examination * valid affiliation to social security * no participation to another research study for the normal-hearing subjects * normal tonal hearing thresholds * normal tympanometry for the subjects without specific language impairment * aged from 6 ro 40 * normal school attendance without scholastic retardation * normal intellectual level * normal for age reading skills * no delayed speech (expression \& production) for the children with specific language impairment * aged fom 8 to 18 * persistent specific literacy difficulties with reading levels at least 18 months behind that of their peers * normal intellectual level for the hearing impaired subjects * age from 18 to 70 * first auditory rehabilitation * bilateral and symmetric hearing loss (±10 db) with hearing thresholds between 0 and 25 db at 0.25 kilohertz, 0 and 35 db at 0.5 kilohertz, 0 and 50 db at 1 kilohertz, 25 and 70 db at 2 kilohertz, 25 and 80 db at 3 kilohertz, 30 and 80 db at 4 kilohertz exclusion criteria: * non signed assent * treatment for depression, epilepsy, parkinson's or alzheimer's disease during more than 6 months * physical health deficiency * mental retardation * neurological or psychiatric disease incompatible with testing procedure for children * known problem of hearing loss or chronic middle ear disease whic compromized the hearing status * schooling in a foreign language * foreign language spoken at home with both parents

Keywords: dyslexia training auditory rehabilitation hearing loss evoked potentials dichotic plasticity noise